European Commission Issues EU Strategy for COVID-19 Vaccines
On 17 June 2020, the European Commission (the Commission) proposed an EU strategy to accelerate the development, manufacturing, and deployment of vaccines against COVID-19 (the Strategy).
The Strategy rests on two pillars.
First, the Strategy aims to support the development and production of COVID-19 vaccines in the EU, thereby securing sufficient supplies of such vaccines, through Advance Purchase Agreements with vaccine producers. Under these Agreements, which will be entered into by the Commission on behalf of the participating Member States, part of the upfront costs faced by vaccines producers will be financed by EU resources in return for the right to purchase any successful vaccine at predefined conditions. The funding will be provided by the Emergency Support Instrument (ESI), which currently has a budget of EUR 2.7 billion. The allocation of the purchased vaccine doses between Member States will take place according to a population-based distribution key. This first part of the Strategy states to be building on the “important groundwork” of the Inclusive Vaccine Alliance which was recently launched by France, Germany, Italy and the Netherlands (see, Van Bael & Bellis Life Sciences News Alert of 15 June 2020 and Van Bael & Bellis Life Sciences News Alert of 4 June 2020). The Strategy says that it will expand the Alliance’s approach.
Second, the Strategy provides for adaptations to the EU regulatory framework to accelerate the development, authorisation and availability of COVID-19 vaccines, while maintaining the standards for vaccine quality, safety and efficacy. In addition to the various initiatives taken by the European Medicines Agency, the Commission proposes to:
(i) reduce its authorisation procedure from nine weeks to one week by shortening the period for consulting Member States and allowing translations of documents after authorisation rather than before;
(ii) loosen its language requirements for labelling and packaging and accept multi-dose presentations for COVID-19 vaccines; and
(iii) derogate temporarily from certain provisions of the GMO Directive for clinical trials with COVID-19 vaccines and treatments that contain or consist of GMOs.
Sensitive to the growing competition among the various joint procurements efforts and the fears voiced by global health groups that low-income countries risk having difficulties to access COVID-19 vaccines, the Commission stresses that it “will ensure that the EU continues to play its part in resolving the COVID-19 crisis for the world” as “[t]he EU will only be safe if the rest of the world is safe”.
Related insightsSign up for updates